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Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00403000
Enrollment
27
Registered
2006-11-23
Start date
2004-12-31
Completion date
2013-04-30
Last updated
2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Brief summary

RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.

Detailed description

OBJECTIVES: Primary * Evaluate the time to disease progression in patients with recurrent prostate cancer that progressed during androgen-deprivation therapy who are treated with dutasteride. * Evaluate the toxicity of dutasteride in these patients. Secondary * Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic response rate in patients treated with dutasteride. * Determine the survival of patients treated with dutasteride. * Determine the quality of life of patients treated with dutasteride. OUTLINE: Patients receive oral dutasteride once daily until disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months thereafter. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Interventions

DRUGdutasteride

Oral

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of prostate cancer * Asymptomatic progressive disease despite androgen-deprivation therapy * Progression must occur during androgen-deprivation therapy comprising orchiectomy or luteinizing hormone-releasing hormone (LHRH) analogue with or without antiandrogen AND after antiandrogen withdrawal * Concurrent LHRH monotherapy (i.e., LHRH analogs, such as leuprolide acetate or goserelin) required in patients who did not undergo prior bilateral orchiectomy to assure testicular androgen suppression * Recurrent disease, as indicated by at least 1 of the following: * Prostate-specific antigen (PSA) at baseline ≥ 2.0 ng/mL * Biopsy-confirmed local recurrence * Increase in size of measurable lesions on radiographic study * New lesion on a nuclear bone scan * Two successive increases in serum PSA measured at least 1 week apart PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Bilirubin ≤ 2.0 mg/dL * SGOT ≤ 4 times upper limit of normal * Creatinine ≤ 2.0 mg/dL * Fertile patients must use effective contraception during and for 3 months after completion of study therapy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 28 days since prior radiotherapy and recovered * At least 28 days since prior flutamide OR at least 42 days since prior bicalutamide or nilutamide * Patients who have previously progressed despite antiandrogen withdrawal and who have started antiandrogens without reduction of serum PSA are eligible without requiring a 28- or 42-day washout interval after antiandrogen withdrawal * No other prior systemic therapies, except androgen-deprivation therapy (i.e., orchiectomy or LHRH analogues only) or antiandrogens * Surgery, brachytherapy, external-beam radiotherapy, and cryotherapy are not considered systemic therapies * No other concurrent anticancer therapy * No concurrent use of any of the following: * Finasteride * Other investigational 5α-reductase inhibitors * Anabolic steroids * Alpha-receptor blockers (e.g., indoramin, tamsulosin hydrochloride, prazosin, terazosin, alfuzosin hydrochloride, and doxazosin) * Drugs with antiandrogenic properties (e.g., spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, and progestational agents) * Products containing selenium ≥ 75 mcg or vitamin E ≥ 100 IU * Saw palmetto * EG6761 * No concurrent radiotherapy, including palliative radiotherapy for pain control

Design outcomes

Primary

MeasureTime frame
Time to disease progressionEvery 12 weeks
ToxicityDaily while on Treatment

Secondary

MeasureTime frame
Objective response (complete and partial) rate and serum prostate-specific antigen levelsEvery 4 weeks
SurvivalEvery 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026